Strategic Expansion and Development of Droplet Digital PCR (ddPCR) Portfolio
Completion of the development of the QX Continuum platform and successful acquisition of Stilla Technologies, adding new platforms and team members.
Launch of the rebranded QX700 Series ddPCR instruments synchronized with the Stilla acquisition, aimed at expanding the ddPCR portfolio.
Early positive customer feedback on the new ddPCR platforms, with plans to showcase innovations at the ddPCR World Conference in Seoul, Korea, in September.
Support for partners like Incyte and Genoscopy in bringing ddPCR technology to clinical markets, including FDA approval support and inclusion in NCCN guidelines.
Market expansion strategy to increase the number of ddPCR users, not just replacing existing platforms but broadening application scope.
Reported Q2 revenues of $720 million and adjusted EBITDA of $184 million, with confidence in raising 2025 guidance.
Emphasized diversified portfolio and multiple growth drivers including new product launches, complex medicines, biosimilars, and strategic partnerships.
Projected continued growth with a focus on innovative and affordable medicines, aiming to be America's #1 affordable medicines company.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
Rapid Adoption and Market Impact of IDEXX inVue Dx Platform
InVue Dx placements reached nearly 2,700 units globally by June 2025, exceeding initial expectations and leading to an increased placement forecast of 5,500 units for 2025.
Early customer feedback highlights the platform's workflow efficiency, rapid turnaround, and AI-powered diagnostic confidence.
InVue Dx is expected to support long-term recurring revenue growth, with upcoming launches like FNA for lumps and bumps.
Demand exceeds expectations, with high customer retention and strong demand for consumables, contributing to a 23% year-over-year increase in premium instrument placements.
The platform is reshaping point-of-care cytology testing, with a focus on high-quality, rapid results that support broader adoption in wellness and diagnostic workflows.
FDA Priority Review and Regulatory Progress for Ziftomenib
The FDA has accepted Kura's NDA for ziftomenib in relapsed/refractory NPM1-mutant AML, granting a priority review with a PDUFA date of November 30, 2025.
Management reports ongoing collaborative and constructive interactions with the FDA, emphasizing alignment with the review timeline.
Regulatory milestones include addressing information requests and preparing for pre-approval inspections, with a focus on ensuring a successful review outcome.
Regulatory Progress and BLA Submission Strategy for INO-3107
Inovio remains on track to submit its BLA for INO-3107 in the second half of 2025, with a goal of file acceptance by year-end.
The company has completed the design verification testing of the CELLECTRA 5PSP device, a key regulatory milestone.
Inovio has requested a rolling submission of its BLA under breakthrough therapy designation, aiming for a 6-month review period and a potential PDUFA date around mid-2026.
The company successfully completed an FDA inspection of its clinical trial operations, an important step in regulatory compliance.
Differences in trial design and technology, such as DNA medicine versus viral vectors, distinguish INO-3107 from competitors' programs.
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